Vivasure Medical announces FDA IDE approval to initiate US pivotal study


Vivasure Medical has announced that the US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to advance the company’s PATCH clinical study, a multicentre, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal closure device system.

The PATCH pivotal study will enrol up to 188 patients across the USA and Europe. The company intends to use the clinical study results to support an FDA premarket approval submission as well as multinational commercial launch of the PerQseal system for large hole vessel closure.

The company also announced that Haemonetics Corporation invested €30 million in the company as part of its Series D financing, the initial tranche of which closed in May 2022. Haemonetics is a global healthcare company providing innovative medical products and solutions for interventional cardiology and electrophysiology procedures, the surgical suite, hospital transfusion services, and blood and plasma component collection. The strategic investment by Haemonetics includes an option to acquire Vivasure Medical upon completion of certain milestones.

“We are excited to be moving forward with this multicentre pivotal study which we expect will affirm the safety and effectiveness of PerQseal for large hole arterial closure. Moreover, we are delighted to now be partnered with Haemonetics, which has quickly established itself as a market leader in advanced vessel closure,” said Andrew Glass, chief executive officer of Vivasure Medical. “We strongly believe in the potential of our fully absorbable patch-based approach to large hole closure, and these steps mark important progress toward fulfilling our mission of enabling safe and effective advanced structural and percutaneous cardiovascular therapies.”

“Vascular closure is a key focus of Haemonetics’ growth strategy, and we are excited about the long-term potential of Vivasure’s innovative technology to advance large hole percutaneous procedures,” said Stew Strong, president, Global Hospital at Haemonetics.

Large hole arterial access is required for clinicians to perform numerous percutaneous cardiovascular procedures such as transcatheter aortic valve replacement (TAVR), thoracic and abdominal endovascular aneurysm repair (TEVAR and EVAR), and the use of a cardiac assist device (CAD). The current approach to large-diameter arterial closure is a surgical repair or the use of suture- or collagen-based closure devices. Both can result in major vascular complications, such as vessel distortion at the closure site, which may lead to stenosis, thrombus formation or abrupt closure.

PerQseal is designed to be the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. Its low profile patch can be placed from inside the vessel and is intended to make deployment simpler and more controlled than conventional closure techniques. Clinical studies to date have shown a low complication rate and high technical success.


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